- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048408
Comparison of Respiratory Muscle, Pain, Functional Performance and Cognitive Status in Obstructive Lung Diseases
July 28, 2020 updated by: Naciye Vardar-Yagli, Hacettepe University
Assessment of Cognitive Status, Pain, Functional Status, Postural Awareness, Respiratory Muscle Strength and Endurance in Obstructive Pulmonary Diseases
In the literature, there are a limited number of studies evaluating postural awareness, cognitive status, respiratory muscle strength and endurance, functional capacity, and pain in people with obstructive pulmonary disease, and comparing these parameters with each other and with healthy subjects, and most of the studies are on chronic obstructive pulmonary disease patients.
There we will evaluate these parameters in different obstructive lung diseases and compare the findings of healthy individuals.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
63
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Please Choose A State
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Ankara, Please Choose A State, Turkey, 06100
- Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Obstructive lung diseases in 18-65 years old
Description
Inclusion Criteria for obstructive lung diseases
- To be diagnosed with obstructive pulmonary disease,
- Have not experienced acute exacerbation in the last 3 months,
- Being between the ages of 18-65,
- Not having chronic pain problems,
- Volunteer for research,
- To be able to walk and cooperate.
Exclusion criteria for obstructive lung diseases
- To be able to diagnose neurological disorder,
- To have an advanced orthopedic disease that may affect functional capacity measurement.
Criteria for Non-Inclusion for healthy group
- To have any cardiopulmonary disease,
- To have an advanced orthopedic disease that may affect functional capacity measurement.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Obstructive lung diseases group
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Healthy group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Perception
Time Frame: 01.01.2019-31.08.2019
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Pain Perception Threshold and Tolerance With Algometer
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01.01.2019-31.08.2019
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cognitive Function Assessment
Time Frame: 01.01.2019-31.08.2019
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Montreal Cognitive Assessment Test (MoCA)
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01.01.2019-31.08.2019
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Functional capacity assesment
Time Frame: 01.01.2019-31.08.2019
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6 minute walk test
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01.01.2019-31.08.2019
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Postural awareness assesment
Time Frame: 01.01.2019-31.08.2019
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Body Awareness Questionnare is a likert type questionnare and total score ranges from 18-126.
Higher scores mean better body awareness level
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01.01.2019-31.08.2019
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Respiratory muscle strength and endurance measurement
Time Frame: 01.01.2019-31.08.2019
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Mouth pressure measurement
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01.01.2019-31.08.2019
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ebru Calik Kutukcu, PhD, Hacettepe University
- Principal Investigator: Melda Saglam, PhD, Hacettepe University
- Principal Investigator: Deniz Inal Ince, Professor, Hacettepe University
- Principal Investigator: Hulya Arikan, Professor, Hacettepe University
- Study Director: Naciye Vardar Yagli, PhD, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
June 24, 2020
Study Completion (Actual)
June 24, 2020
Study Registration Dates
First Submitted
August 6, 2019
First Submitted That Met QC Criteria
August 6, 2019
First Posted (Actual)
August 7, 2019
Study Record Updates
Last Update Posted (Actual)
July 29, 2020
Last Update Submitted That Met QC Criteria
July 28, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 18/109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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